Health Decisions CEO Explores Adaptive Monitoring Techniques for Late-Stage Clin

ical Studies in June 14 DIA Session

Dr. Michael Rosenberg will describe how fast access to metrics, flexible process
es, and automated technology enable study monitors to increase efficiency
Durham, NC, June 10, 2010 -- Health Decisions (www.HealthDec.com, Booth 929), a
full-service clinical research organization (CRO) specializing in high-efficienc
y adaptive solutions, announces that CEO Michael Rosenberg, MD, MPH will join a
panel June 14 at the DIA Annual Meeting in Washington, DC. Centralized Monitorin
g: When Does It Make Sense? will focus on the advantages and requirements of mon
itoring programs that balance the needs of sponsor companies and investigative s
ites in phase IIIb to postmarket clinical studies.
According to Dr. Rosenberg, a centralized monitoring system should be based on t
he same general principle as adaptive design, a hot topic in the industry. Adapt
ive monitoring involves capturing and presenting site performance metrics to stu
dy monitors in near-real time, allowing monitors to make mid-course adjustments
to study operations based on current information. This enables decision-makers t
o optimize site activity on a rolling and continuous basis for dramatic aggregat
e time- and cost-savings.
“Applied to site management, adaptive methodology empowers monitors to be more t
han just box-checkers,” said Dr. Rosenberg. “Each team member has the training a
nd tools to improve site performance. When the whole team is thinking critically
about the overall health of the study, you get better quality data and faster e
xecution at every stage, from start-up and enrollment through database lock and
submission.”
Centralized Monitoring: When Does It Make Sense? will explore monitoring solutio
ns that provide economies of scale, allocate resources efficiently, optimize eve
ry aspect of operations, and alleviate sponsors’ concerns about budget and timel
ines. Such solutions include:
Need-based monitoring visits: how to reliably and efficiently determine when to
dispatch monitors to sites
Managing based on performance metrics: which metrics to look for, how to track a
nd report trends, and what actions to take when opportunities to improve efficie
ncy are indicated
Automated data capture and processing tools
Electronic data as source documents
The session will be chaired by Ramita Tandon, MPH, MSc, senior director, project
management, per-approval services (PACE) at PAREXEL International. The session
is part of the Clinical Research and Development/Clinical Supplies (CR/CS) track
, and takes place June 14 from 3:30 – 5:00 p.m. EDT in Room 145B.
For media information, please contact Katie Hendrick, Marketing Specialist at kh
endrick@HealthDec.com; +1.919.967.1111 x116.
For sales and marketing information, please contact Dean Bundschu, VP of Busines
s Development at dbundschu@HealthDec.com; +1.919.967.1111 x510.
About Health Decisions
Health Decisions (www.HealthDec.com) is a global clinical research organization
(CRO) committed to helping drug and device companies achieve greater success. Ou
r sponsors rely on us to help them prove the value of their pipelines both faste
r and with the smartest possible allocation of funds. Through Agile Clinical Dev
elopment—a strategic combination of adaptive design and adaptive operations—Heal
th Decisions optimizes every facet of clinical research from design protocol to
the most detailed day-to-day management, so sponsors can make the most of compet
itive market opportunities.
Health Decisions is headquartered in Durham, NC, with over twenty years of exper
ience helping sponsors achieve success in Phase I-IV trials across all major the
rapy areas. For more information, please visit the company s website at www.Heal
thDec.com.
About the DIA Annual Meeting
Hosted by the Drug Information Association, the DIA 46th Annual Meeting takes pl
ace June 13 – 17, 2010 at the Walter E. Washington Convention Center, Washington
, DC. The DIA Annual Meeting is the biopharmaceutical industry s largest, longes
t running, best-value, global, multidisciplinary event. To learn more, visit DIA
online.
About the Drug Information Association (DIA)
DIA (www.diahome.org) is a neutral, global, professional, member-driven associat
ion of nearly 18,000 industry, academia, and regulatory professionals involved i
n the discovery, development, and life cycle management of pharmaceuticals, medi
cal devices, and related products. Through our international educational offerin
gs and myriad networking opportunities, DIA provides a global forum for knowledg
e exchange that fosters the innovation of products,€technologies, and services t
o improve health and well-being worldwide. Headquarters are in Horsham, PA, USA,
with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, C
hina.
Contact:
Katie Hendrick
Health Decisions
2510 Meridian Parkway
Durham, NC 27713 US
+1.919.967.1111 x116
Khendrick@HealthDec.com
http://www.HealthDec.com